Search

Abstract Introduction Patients with alopecia areata (AA) may have received several therapies for management of AA during their lives. In the ALLEGRO phase 2b/3 (NCT03732807) study, the oral JAK3/TEC family kinase inhibitor ritlecitinib demonstrated efficacy and an acceptable safety profile in patients aged ≥ 12 years with AA and ≥ 50% scalp hair loss. This post hoc analysis investigated associations between prior use of AA therapies and Severity of Alopecia Tool (SALT) responses in patients receiving ritlecitinib for AA. Methods Patients receiving ritlecitinib 30 mg or 50 mg once daily with or without an initial 4-week 200-mg daily loading dose were grouped by previous exposure to AA treatments, including topicals, intralesional corticosteroids (ILCS), topical immunotherapy, and systemic immunosuppressants or any prior AA treatment. Multivariable logistic regression analyses evaluated the association between response based on a SALT score of ≤ 20 and any prior treatment for AA at weeks 24 and 48. Results Of 522 patients, 360 (69.0%) had previous exposure to any AA treatment. At Week 24, SALT ≤ 20 response was positively associated with prior use of ILCS (odds ratio [OR], 2.12; 95% confidence interval [CI], 1.23–3.65; P 0.05). Previous exposure to any AA therapy was not associated with SALT ≤ 20 response at weeks 24 or 48 (all P > 0.05). Conclusions Prior AA treatment history had no effect on longer-term treatment response to ritlecitinib. Trial Registration Number NCT03732807. Graphical Abstract

Abstract Background Rates of keratinocyte carcinoma (KC) across Europe are impacted by population demographics and geography. Regional differences in KC occurrence exist, but few European studies investigate incidences of specific subtypes in the secondary healthcare sector on a national level. Objectives To determine geographical differences in incidence rate and lifetime risk of KC subtypes across Denmark, including nodular and superficial basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and the KC precursor, Bowen's disease (BD), identified in office‐based dermatological practice. Methods Based on a nationwide registry (The Danish Skin Cancer Registry), all patients in Denmark's five regions with a histologically‐ or clinically verified KC or BD registered in a state‐funded office‐based dermatology practice between 2013 and 2022 were included. Trends in national‐ and region‐specific age and sex standardised tumour incidence rates (STIR) were calculated. Further, national lifetime risk of each tumour subtype was estimated. Results Between 2013 and 2022, the combined STIR for KC/BD rose 172% nationally from 180 to 489 per 100,000 person‐years (PY). This increase reflected rising rates of nodular BCC, SCC, and BD, while superficial BCC incidence was relatively stable. Regional differences in STIR for combined KC/BD were observed, with the Capital Region and North Jutland generally demonstrating higher rates than Zealand, Southern‐ and Central Denmark (e.g., North Jutland vs. Southern Denmark: 714 vs. 405/100,000PY). While the estimated lifetime risk of developing at least one KC or BD tumour was 21.8%, risk varied with tumour subtype, resulting in subtype‐specific risks of 16.4%, 5.1%, 1.9% and 1.3% for nodular BCC, superficial BCC, SCC, and BD, respectively. Conclusions In Denmark's secondary dermatological care sector, incidence of nodular BCC, SCC and BD continues to rise with an overall lifetime risk nearing 22%. While KC incidence is increasing in Denmark, the study detected differences in geographical trends and rate increases of specific tumour subtypes.

Background: Alopecia areata (AA) and atopic dermatitis (AD) are chronic skin diseases where the suboptimal medication adherence (MA) may result in poor clinical outcomes. Objective: To assess the impact of AA on MA among adults compared to AD. Methods: Patient reported MA of adults with AA were compared with AD. Patients were identified from the Danish Skin Cohort, a nationwide prospective cohort of dermatological patients in Denmark. We used the Medication Adherence Report Scale- 5, a self-reporting questionnaire, to assess MA. Demographic and disease characteristics were collected. Logistic regression was conducted. Results: Patients with AA reported higher MA than AD (mean 21.81 vs 18.29). Logistic regression analyses showed AA diagnosis had a statistically significant positive effect on MA (odds ratio = 3.94, 95% CI 2.01-8.89). Men reported significantly higher MA (odds ratio = 1.49, 95% CI 1.14-1.94). Current disease severity did not impact MA. Limitations: Data were self-reported by patients. Data regarding the specific treatment undergone by patients were not available. Conclusion: Patients with AA have significantly higher MA compared to patients with AD. The stability of AA patients’ symptoms may lead to higher MA due to a desire for disease control. Conversely, the sporadicity of AD symptoms could negatively affect adherence, causing fluctuations in medication use.

Background: Oral Janus kinase inhibitors (JAKis) have black-box warnings of infections, cancer risk, and cardiovascular and venous thromboembolic events. They may be used off-label for chronic hand eczema (CHE). Objectives: Assess the prevalence of risk factors potentially impacting oral JAKi safety in CHE patients. Methods: In the Danish Skin Cohort, CHE patients were examined for risk factors affecting oral JAKi use at baseline and followed for 12 months. Data were collected through register linkage (eg, cancer history) and through patient interviews (eg, smoking habits). Results: Of 941 adults with CHE (66.2% women; mean age 55.5 [SD 13.3] years), 768 (81.6%) patients had at least one risk factor potentially impacting oral JAKi use, of which 682 (72.5%) had nonmodifiable risk factors. Most common risk factors were current or former heavy smoking (62.8%, n = 591), obesity (28.1%, n = 264), hypercholesterolemia (21.5%, n = 202), and hypertension (18.8%, n = 177). Among patients without any risk factors at baseline (n = 173), 20.2% (n = 35) developed ≥1 risk factor during the following 12 months. Limitations: Certain risk factors may be underreported. Conclusion: Most CHE patients have risk factors limiting appropriateness of oral JAKi use. Health care providers should assess risk factors in their patients when choosing treatment for CHE.

Abstract Introduction Alopecia areata (AA) is an autoimmune disease associated with high rates of emotional and psychosocial distress. The analysis reported here describes the evolution of measures assessing health-related quality of life (HRQoL) and symptoms of anxiety and depression up to week 104 in patients who achieved sustained scalp hair regrowth during treatment with baricitinib in the BRAVE-AA phase III trials. Methods This post-hoc analysis included data from the double-blind, parallel-group, randomized, placebo-controlled phase III trials BRAVE-AA1 (ClinicalTrials.gov number: NCT03570749) and BRAVE-AA2 (ClinicalTrials.gov number: NCT03899259). Adults with severe AA (defined as a Severity of Alopecia Tool [SALT] score ≥ 50) randomized to baricitinib 4 mg or baricitinib 2 mg at baseline who achieved SALT score ≤ 20 by week 36 and maintained SALT score ≤ 20 through week 104 on the same dose of baricitinib were included in this analysis of integrated data. Scalp hair regrowth (SALT score) and improvements in Skindex-16 AA Scale and Hospital Anxiety and Depression Scale (HADS) domain scores were analyzed over the 104-week period using descriptive statistics. Results In total, 131 patients (88 on baricitinib 4 mg and 43 on baricitinib 2 mg) were included in this analysis. Across the two groups, the mean age (standard deviation) was 37.2 years (12.7), and 84 (64.1%) patients were female. The interquartile range (IQR) for time to achieve a SALT score ≤ 20 for patients treated with baricitinib 4 mg and baricitinib 2 mg was 13.1 and 19.6 weeks, respectively. By week 104, 91% (baricitinib 2 mg) and 96% (baricitinib 4 mg) of patients had achieved a SALT score ≤ 10 on baricitinib treatment. In both groups, progressive improvements in the Skindex-16 AA and HADS domain scores were observed up to week 104. Conclusion This analysis of adults with severe AA treated with baricitinib revealed that achievement of sustained clinically meaningful scalp hair regrowth (SALT score ≤ 20) was associated with improvements in both measures of HRQoL and symptoms of anxiety and depression up to week 104.

Abstract Background Dermatological diseases may cause significantly impaired quality of life, however patient reported outcomes are often disease specific, and not comparable across diseases. Objectives To examine daily time trade‐off (dTTO), as a measure of disease burden. Methods An epidemiological study based on patient data from Danish Skin Cohort (prospective cohort of Danish dermatology patients) was conducted. Data were linked with routinely collected data from Statistics Denmark. We included adults with either alopecia areata (AA), atopic dermatitis (AD), hidradenitis suppurative (HS), psoriasis, or rosacea. All patients with a diagnostic code listed above were invited to participate. The primary outcome was defined as a dTTO of more than 30 minutes daily. Results A total of 680, 1605, 611, 1664, and 1698 adults with AA, AD, HS, psoriasis, and rosacea, respectively, were included. In multiple regression models, patients with AA were most likely to have a dTTO of more than 30 minutes, followed by patients with HS, AD, psoriasis and rosacea. A total of 33.7% (AA), 29.3% (HS), 14.6% (AD), 11.1% (psoriasis), and 9.0% (rosacea) of patients were willing to spend two hours or more per day. The dTTO correlated with disease severity and DLQI across disease groups. Conclusions Patients with AA, followed by HS were willing to spend most time on treatment, possibly reflecting unmet needs in these patient groups. Daily TTO correlated with perceived disease severity in all groups and may be a useful measure of dermatological disease burden.

Abstract Background Patients with hidradenitis suppurativa (HS) experience fatigue, but no studies have yet examined the association between HS severity and fatigue intensity. Objectives To examine the possible association between HS severity and fatigue and identify fatigue subtypes present in patients with HS. Methods Adult patients with HS participated in a survey assessing fatigue using the Multidimensional Fatigue Inventory‐20. Disease severity was determined by self‐report. Results Data from 654 adult patients with HS were analysed and compared with 3,788 reference individuals from the general population. Total and subtype fatigue scores for patients with HS were significantly higher compared with the general population reference individuals and increased with higher HS severity, itch, pain, sleep, dermatology life quality index scores and lower socioeconomic status. The association between HS severity and increased fatigue scores remained statistically significant after adjustment for age, sex, and socioeconomic status. Conclusions Patients with HS had a significantly higher fatigue score compared with the general population reference individuals in a severity‐dependent manner. A higher awareness of fatigue as a symptom in patients with HS is warranted.

Background: Biomarkers associated with disease severity and comorbid metabolic syndrome (MetS) in patients with hidradenitis suppurativa (HS) are lacking. Objective: To identify biomarkers associated with disease severity and comorbid MetS in patients with HS. Methods: Data on hospital outpatients with HS were obtained through clinical examination and interviews. Indicators of systemic inflammation; C-reactive protein (CRP), erythrocyte sedimentation-rate (ESR), neutrophil/lymphocyte-ratio (NLR), platelet/lymphocyte-ratio (PLR), monocyte/lymphocyte-ratio (MLR), platelet/neutrophil-ratio (PNR), pan-immune-inflammation-value (PIV), and systemic-immune-inflammatory-index (SII), were calculated from blood samples. Results: Seven hundred patients were included; of those 444 (63.4%) and 256 (36.6%) were female and male, respectively, with a median age of 38.3 years (IQR = 27.9-51.0). Increasing CRP, ESR, NLR, PIV, and SII (P

Background: The risk of cardiovascular disease in atopic dermatitis (AD) is not well established. Objectives: Our aims were to evaluate the incidence rate (IR) of venous thromboembolism (VTE) in patients with AD in a population-based cohort study and to assess atherosclerotic cardiovascular disease (ASCVD) risk factors and incidence of malignancies, major adverse cardiovascular events (MACE), and VTE in patients with AD and rheumatoid arthritis (RA) in a nested cohort analysis. Methods: Data from individuals age 12 years or older (nested cohort age ≥ 18 years) from January 1, 2000, to December 31, 2018, were extracted from the Danish National Patient Registry. Patients with AD were age- and sex-matched with 10 healthy controls. ASCVD risk factors included age 65 years or older and history of smoking, coronary artery disease, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and malignancy. Results: The population-based cohort comprised 190,751 patients (17,341 patients with AD and 173,410 healthy controls). The IRs per 100 patient-years were comparable between the AD cohort and healthy controls for VTE (0.14 [95% CI = 0.12-0.16] vs 0.11 [95% CI = 0.11-0.12]), DVT (0.08 [95% CI = 0.06-0.09] vs 0.06 [95% CI = 0.06-0.07]), and PE (0.06 [95% CI = 0.05-0.08] vs 0.05 [95% CI = 0.05-0.05]). The IR for VTE was higher in the AD cohort age 65 years or older (0.71 [95% CI = 0.56-0.90]) than in the age-matched controls (0.50 [95% CI = 0.46-0.54]). ASCVD risk factors were more frequent in the patients with RA than in the patients with AD. The IRs for malignancies and MACE were higher with specific ASCVD risk factors. Conclusions: The IRs of cardiovascular events were comparable between the AD cohort and general population. The risk of VTE, malignancy, or MACE was higher with specific ASCVD risk factors, underscoring the need for patient monitoring.

Abstract Introduction Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of moderate-to-severe plaque psoriasis. Since scalp psoriasis can be burdensome and challenging to treat with non-systemic therapies, this post hoc analysis focused on scalp psoriasis in patients with moderate-to-severe plaque psoriasis and baseline scalp involvement. The analysis considered a holistic concept of clearance through 5 years of ixekizumab treatment. Methods Ixekizumab-treated patients with baseline scalp involvement were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials (integrated UNCOVER-1/2 and UNCOVER-3). Analyses were performed on a subpopulation of patients who achieved complete resolution of scalp psoriasis at Week 60 (i.e., Week 60 Psoriasis Scalp Severity Index [PSSI-0] responders) and on the overall patient population (i.e., Week 60 PSSI-0 responders and non-responders), which was used as a reference. Clinical outcomes (PSSI), patient-reported outcomes (Itch Numeric Rating Scale [NRS] score, Skin Pain Visual Analogue Scale [VAS]), quality of life (Dermatology Life Quality Index [DLQI]), and concurrent outcomes were assessed from baseline through 5 years. Descriptive statistics of observed data were reported. Results After 60 weeks of ixekizumab treatment, 88.4% (UNCOVER-1/2) and 75.9% (UNCOVER-3) of patients with baseline scalp involvement achieved complete clearance (PSSI-0) of scalp psoriasis. Substantial improvements in the clinical outcomes (PSSI), patient-reported outcomes (Itch NRS, Skin Pain VAS), and quality of life (DLQI) were achieved by Week 60 and sustained through Week 264 in the Week 60 PSSI-0 responders and in the overall patient population. Additionally, a significant proportion of Week 60 PSSI-0 responders achieved concurrent complete scalp and skin clearance and quality of life improvement through 5 years. Conclusions Continued treatment with ixekizumab provided long-term sustained scalp clearance over 5 years to patients with moderate-to-severe plaque psoriasis and baseline scalp involvement, and holistic improvements occurred across clinical outcomes, patient-reported outcomes, and quality of life. Clinical Trial Numbers NCT01474512 (UNCOVER-1), NCT01597245 (UNCOVER-2), and NCT01646177 (UNCOVER-3).

Abstract Introduction Alopecia areata (AA) is an autoimmune condition that causes non-scarring hair loss and can impose a high psychosocial burden on patients. The presence of comorbid conditions may impact the management of AA in clinical practice. This analysis aims to describe disease characteristics and management of AA in patients with concomitant atopic, autoimmune, and psychiatric comorbid conditions. Methods Data were collected from the Adelphi Disease Specific Programme™, a cross-sectional survey of physicians and their adult patients with AA conducted in France, Germany, Italy, Spain, and the UK between October 2021 and June 2022. Patients’ disease severity was based on physician’s definition. Physician-reported data on demographics, AA clinical characteristics, comorbid conditions, and information related to AA therapies were analyzed. Analyses were descriptive. Results Overall, 239 dermatologists provided data for 2083 patients, of which 558 patients (27%) had at least one atopic, autoimmune, or psychiatric comorbid conditions. The most common comorbid conditions were atopic dermatitis, autoimmune thyroid disease, and anxiety. The mean (standard deviation) patient age for the three comorbidity groups was 37.6 years (12.1) and 56% of the patients were women (n = 313). In the three comorbidity groups, 51%, 50%, and 55% of patients with atopic, autoimmune, and psychiatric comorbidities had severe AA with disease progression reported as worsening in 30%, 28%, and 30%, respectively, whereas in the group with no comorbidities, 37% were described as having severe AA and 21% getting worse. Scalp hair loss was the primary sign reported across the three groups of comorbid conditions (atopic, 91%; autoimmune, 91%; psychiatric, 88%). Patients with preselected comorbidities presented more frequently AA-related signs and symptoms beyond scalp hair loss than patients without comorbid conditions. These patients were also more likely to receive topical calcineurin inhibitors, topical immunotherapy, conventional systemic immunosuppressants, and oral Janus kinase inhibitors for the treatment of their AA. Conclusion This analysis provided insights into the burden and management of AA in patients presenting with atopic, autoimmune, and psychiatric comorbid conditions in five European countries.

Abstract Introduction This study aimed to understand treatment response dynamics, including factors associated with favorable response, among patients with moderate-to-severe psoriasis who received guselkumab, adalimumab, or secukinumab. Methods These post hoc analyses used data from the phase III clinical trials ECLIPSE and VOYAGE 1, which were conducted between September 2021 and November 2022. On the basis of absolute Psoriasis Area and Severity Index (aPASI) scores, patients were divided into short-term response types (SRT1–6, based on week 20–48 response) and long-term response types (LRT1–4, based on week 52–252 response). Response types (RTs) were based on aPASI cutoffs deemed clinically relevant by the investigators; SRT1/LRT1 were the most favorable response types. Baseline characteristics were compared across RTs, and logistic regression analyses established factors associated with SRT1/LRT1. Results Overall, 1045, 662, and 272 patients were included in the ECLIPSE short-term, VOYAGE 1 short-term, and VOYAGE 1 long-term analyses, respectively. Mean age, body mass index (BMI), baseline aPASI score, and body surface area were lower in SRT1 than SRT6. In VOYAGE 1, adalimumab treatment, high BMI, and current/former smoking status resulted in less favorable responses. In the VOYAGE 1 long-term analysis, patients in LRT4 had the highest baseline aPASI score, were older, and were more often obese compared with other LRT groups. Regression analyses showed that SRT1 (both treatments) in VOYAGE 1 and ECLIPSE, and LRT1 (guselkumab group) in the VOYAGE 1 long-term analysis, were associated with week 16 aPASI response. In VOYAGE 1, SRT1 was associated with psoriasis duration and smoking status. Conclusions Early treatment response and baseline characteristics, including smoking, psoriasis duration, and obesity, may be associated with longer-term response to biologics. Trial Registration Numbers ECLIPSE: NCT03090100, VOYAGE 1: NCT02207231.

Background: Topical corticosteroids (TCS) are used to treat most patients with chronic hand eczema (CHE), but knowledge about TCS-related adverse events in CHE is limited. Objectives: To investigate patient-reported adverse events to TCS in CHE patients. Methods: Data on adverse events related to TCS use in patients with CHE were analyzed from the Danish Skin Cohort; a prospective survey of a hospital cohort. We assessed patients’ knowledge about TCS use and adverse event risks, and preference of TCS versus a nonsteroidal topical alternative. Results: Of 724 adults with CHE (64.0% women; mean age 57.5 [standard deviation 12.8] years), 64.1% reported skin atrophy, 41.4% cracks/fissures, 23.9% bleeding, 45.9% pain/stinging sensation, 40.0% reduced hand dexterity, and 40.2% worsening of CHE signs or symptoms from using TCS. We observed CHE-severity-dependent associations (all groups; P

Abstract Background Some patients treated with biologic therapy for psoriasis experience adverse events causing treatment discontinuation. Objectives To identify predictors of adverse events resulting in discontinuation of biologics for psoriasis. Methods This cohort study involved data from the Danish nationwide registry DERMBIO. A classification algorithm based on gradient‐boosted decision trees combined with a mixed‐effects model was applied to data on various drugs to predict treatment discontinuation caused by adverse events and to identify important predictors. Results This study comprised 4876 treatment series, including 3078 (63.1%) that were discontinued. With adverse events causing 19.6% of these, it was the second most frequent reason for discontinuation following ineffectiveness. The proportion of treatments discontinued due to adverse events was 20.0% [16.7%, 23.9%; 95% confidence interval (CI)] among patients that had discontinued their previous treatment series due to adverse events, and 11.6% [10.3%, 13.1%; 95% CI] among treatment series where the previous treatment was discontinued due to other reasons (p

Abstract Background The treatment expectations of patients with psoriasis are essential for clinical outcomes. Objectives To examine disease‐ and treatment related intra‐ and interpersonal factors and their relation to treatment expectations among patients with psoriasis who initiate or switch biological therapy. Methods Consecutive adult patients with moderate to severe psoriasis who initiated or switched biological therapy completed a questionnaire regarding their disease‐ and treatment‐related expectations. Additionally, they filled out Patients' Attitudes and Beliefs Scale (PABS), Trust in Physician Scale (TPS) and Dermatology Life Quality Index (DLQI) questionnaires. Psoriasis Area Severity Index (PASI) was scored before and 3 months after treatment initiation. Results A total of 65 patients participated; 28% expected

Abstract Background Limited research has been conducted on whether advances in novel biologics and biosimilars have improved the treatment journey preceding biologics. Objectives To map the overall treatment journey preceding the initiation of first biologic therapy in patients with psoriasis (PsO) and psoriatic arthritis (PsA), as well as the changes over time. Methods Using Danish nationwide registries, we included all patients treated with a first‐time biologic (2010–2018) for either PsO or PsA and reported the medical treatment journey. We used Sankey diagrams to illustrate the flow of treatment series. Results The study included 2082 patients with PsO (62.5% male) and 1831 patients with PsA (42.3% male). Before biologics, 49.5% treated for PsO and 36.8% treated for PsA received ≥2 type therapies and 59.3% with PsO and 25.5% with PsA received ≥3 treatment series. Median time from first systemic therapy to a biologic was 3.9 years (Q1–Q3, 1.3–4.1) for PsO and 2.1 years (Q1–Q3, 0.6–5.8) for PsA. The majority of patients with PsO (1174 [56.4%]) received multiple treatment series with the same drug, while almost a third of patients with PsA (572 [31.2%]) did the same. Twelve percent of patients with PsO and 6.4% of patients with PsA repeated treatment with a drug they had already stopped for an alternative treatment. Conclusions Although most patients are adequately managed, our findings suggest the possibility of a yet too long and complicated treatment journey before starting biologics.

Abstract Background Generalized pustular psoriasis (GPP) is an inflammatory skin disease characterized by episodic flares of erythematous painful skin with widespread sterile pustules. The disease is a rare and potentially life‐threatening variant of psoriasis. To date, little is known about the incidence and prevalence of GPP; possibly due to the rarity of the disease. Objectives The objective of this study was to examine the incidence and prevalence of patients with GPP in Denmark. Methods The incidence and prevalence of GPP were calculated based on data from the Danish nationwide administrative registries. We identified patients with incident GPP as those recorded with a first‐ever diagnostic code for GPP between 1 January 1997 and 31 December 2018. The prevalence of GPP was estimated based on all Danes alive and resident in the source population on 31 December 2018. Results The incidence rates of GPP varied from 0.14 to 0.43 per 100,000 person‐years in a period spanning 22 years (1997–2018). There was generally a strong female predominance among patients diagnosed with GPP, and mean age at the time of diagnosis varied from 47 to 64 years in the study period. We estimated the lifetime prevalence of GPP to be 0.0111%, or 11.1 per 100,000 Danish residents. Conclusions Our findings indicate that the incidence rates of GPP have remained stable in a time‐period spanning 22 years from 1997 to 2018, however, the rate of inpatient hospitalizations did appear to be somewhat decreasing in more recent years.

Abstract Background Psychiatric co‐morbidity (PCM) constitutes a major complicating factor for patients with hidradenitis suppurativa (HS) but individuals at risk are ill defined. Objectives To examine the differences in demographic and clinical characteristics, co‐morbidities, and disease burden in patients with HS with and without PCM. Methods Data were obtained through clinical examination and interviews. Disease burden was evaluated based on clinical severity, VAS‐10 for overall bother and pain, and dermatology life quality index. Analysis was conducted on all patients and amongst PCM‐subgroups. All current physician diagnosed psychiatric conditions were included. Results 667 consecutive, adult patients with HS from a dermatological university outpatient clinic were included. Of these, 183 (27.4 %) had a diagnosis of PCM, with affective disorders (16.2%) being most prevalent. PCM was associated with being unemployed (52.5 vs. 18.7 %) OR 5.50 (3.73–8.10) p

(1) Background: The purpose of this study is to compare the rate of COVID-19 vaccination among psoriasis patients internationally and to correlate it with their treatment regimens. (2) Methods: We conducted a cross-sectional study from January 2021 to October 2022 among adults in the United States (US), Chile, China, Switzerland, and Singapore using the Global Healthcare Study on Psoriasis survey. (3) Results: A total of 310 psoriasis patients in the US (98), Chile (32), China (80), Switzerland (39), and Singapore (61) were surveyed. Of these, 248 patients (80.0%) were vaccinated at least once for COVID-19 (Chile: 100%, Singapore: 100%, US: 93.9%, Switzerland: 69.2%, China: 45.0%). Compared with other countries, patients in China were 89% less likely to report at least one COVID-19 vaccination (1 − 0.11 = 0.89; OR 0.11; 95% CI: 0.03–0.48), and patients in Switzerland were 80% less likely (1 − 0.20 = 0.80; OR 0.20; 95% CI: 0.05–0.79). Compared with patients on biologics, patients on topicals were 10.9 (95% CI: 2.1–56.6) times more likely to report at least one COVID-19 vaccination, and patients on oral systemics were 7.2 times more likely (95% CI: 1.6–31.6). (4) Conclusions: Country of residence and treatment regimen are associated with different COVID-19 vaccination rates in psoriasis patients.

Quality of life impairment in dermatology patients and severity of psoriasis are quantified by the Dermatology Life Quality Index (DLQI) and the Psoriasis Area and Severity Index (PASI), respectively. The aim of this study is to compare the correlation between PASI and DLQI in patients from different geographical areas and to identify predictors of high DLQI across geographical regions. Correlations between PASI and DLQI were evaluated using Spearman’s rank correlation tests and quantile regression. The study included 1,158 patients with psoriasis, with a median (interquartile range) PASI and DLQI of 6.0 (3.0–12.0) and 8.0 (4.0–15.0), respectively. Correlations were demonstrated between PASI and DLQI, both overall and stratified by geographical region. Quantile (median) regression yielded coefficients of 0.75 (95% confidence interval (95% CI) 0.62, 0.88) for Switzerland, 0.50 (95% CI 0.42, 0.58) for Latin America, 0.34 (95% CI 0.16, 0.51) for Asia, and 0.31 (95% CI 0.08, 0.53) for the USA. Current age, age at diagnosis, sex, body mass index, and psoriasis arthritis affected DLQI in Latin America, while education had an impact among patients treated in Switzerland. Few countries were included within each continent; hence, more data from different countries are necessary for generalizability. The study showed correlations between PASI and DLQI among patients in all included geographical regions. The patients’ characteristics affecting DLQI vary worldwide.

Abstract Studies examining the association between type 1 diabetes (T1D) and atopic diseases, i.e., atopic dermatitis, allergic rhinitis and asthma have yielded conflicting results due to different algorithms for classification, sample size issues and risk of referral bias of exposed cohorts with frequent contact to health care professionals. Using Danish national registries and well-established disease algorithms, we examined the bidirectional association between T1D and atopic diseases in childhood and adolescence using Cox Proportional Hazard regression compared to two different unexposed cohorts from a population of 1.5 million Danish children born from 1997 to 2018. We found no associations between T1D and atopic dermatitis, allergic rhinitis, or asthma (defined after age five). However, in multivariable analysis we found an increased risk of persistent wheezing (defined as asthma medication before age five) after T1D with an adjusted hazard ratio (aHR) of 1.70 [1.17–2.45]. We also identified an increased risk of developing T1D after persistent wheezing with aHR of 1.24 [1.13–1.36]. This study highlights similar risks of atopic diseases in children with T1D and of T1D in children with atopic disease after age of five years versus healthy controls. However, more research is needed to understand the possible early immunological effects of the link between persistent wheezing and T1D.

Abstract Treatments for alopecia areata (AA) have traditionally been prescribed off-label, and there has been no universal agreement on how to best manage the condition. Baricitinib is the first oral selective Janus kinase (JAK) inhibitor approved for the treatment of adults with severe AA. As a better understanding of the evidence supporting the management of AA in clinical practice is needed, we conducted a systematic literature review and subsequent narrative review to describe available evidence pertaining to the efficacy and tolerability of treatments currently recommended for adults with moderate-to-severe forms of AA. From 2557 identified records, a total of 53 records were retained for data extraction: 9 reported data from 7 randomized controlled trials (RCTs) versus placebo, and 44 reported data from unique RCTs with no placebo arm, non-randomized trials, or observational studies. Across drug classes, data were reported heterogeneously, with little consistency of data collection or clinical endpoints used. The most robust evidence was for the JAK inhibitor class, in particular the JAK1/JAK2 inhibitor baricitinib. Five RCTs (three for baricitinib) demonstrated a consistent benefit of JAK inhibitor therapy over placebo across various clinical outcomes in adult patients with at least 50% scalp hair loss. Overall, hair regrowth varied widely for the other drug classes and was generally low for patients with moderate-to-severe AA. Relapses were commonly observed during treatment and upon discontinuation. Adverse effects were generally consistent with the known safety profile of each intervention. The heterogeneity observed prevented the conduct of a network meta-analysis or an indirect comparison of different treatments. We found that the current management of patients with moderate-to-severe AA often relies on the use of treatments that have not been well evaluated in clinical trials. The most robust evidence identified supported the use of baricitinib, and other oral JAK inhibitors, in patients with severe AA.

Abstract Background Nail psoriasis is a common, physiologically, and psychologically disruptive, and yet often under-treated manifestation of psoriasis. The objectives of this analysis were to investigate the trajectory of nail psoriasis, a risk factor for psoriatic arthritis (PsA), with guselkumab vs adalimumab treatment followed by withdrawal, and determine characteristics associated with nail response in patients treated with guselkumab. Methods This post hoc analysis of the phase III trial VOYAGE 2 included patients with moderate-to-severe plaque psoriasis and baseline nail involvement. Nail Psoriasis Severity Index (NAPSI) and Psoriasis Area and Severity Index (PASI) were analyzed through week 48 in patients randomized to guselkumab or adalimumab. Multiple logistic regression analyzed factors associated with NAPSI 0/1 at week 24/week 48 following guselkumab treatment. In a separate analysis, patients were stratified by prior biologic experience. Results Overall, 272 vs 132 patients receiving guselkumab vs adalimumab had nail psoriasis at baseline. Lower baseline NAPSI and week 16 PASI were associated with achieving NAPSI 0/1 at week 24 (NAPSI, odds ratio 0.685 [95% confidence interval: 0.586, 0.802]; week 16 PASI, 0.469 [0.281, 0.782]) and week 48 (NAPSI, 0.784 [0.674, 0.914]; week 16 PASI, 0.557 [0.331, 0.937]) with guselkumab. Previous biologic experience did not impact NAPSI response. Following treatment withdrawal at week 28, mean NAPSI was maintained in the guselkumab arm (week 24 1.7, week 48 1.9) and increased slightly in the adalimumab arm (week 24 1.4, week 48 2.3). Mean PASI increased across both treatment arms. Conclusions Higher skin efficacy at week 16 was associated with better nail responses during guselkumab treatment. Nail psoriasis improvements reflected skin improvements. Following guselkumab withdrawal, nail response was maintained longer than skin response. Future studies should investigate whether such improvements in nail response reduce patients’ risk of later PsA development. Trial registration ClinicalTrials.gov, NCT02207244. Registered July 31, 2014.

Abstract Nail psoriasis is a difficult-to-treat manifestation of psoriatic disease affecting up to 80% of patients with psoriatic arthritis (PsA) and 40–60% of patients with plaque psoriasis (PsO). Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of patients with PsA and patients with moderate-to-severe PsO. This narrative review aims to summarize nail psoriasis data generated from IXE clinical trials in patients with PsA (SPIRIT-P1, SPIRIT-P2, and SPIRIT-H2H) and/or moderate-to-severe PsO (UNCOVER-1, -2, -3, IXORA-R, IXORA-S, and IXORA-PEDS) with an emphasis on head-to-head clinical trial data. Across numerous trials explored, IXE treatment was associated with greater improvement in resolution of nail disease versus comparators at week 24, results which were maintained up to and beyond week 52. Additionally, patients experienced higher rates of resolution of nail disease versus comparators at week 24 and maintained high levels of resolution up to week 52 and beyond. In both PsA and PsO, IXE demonstrated efficacy in treating nail psoriasis, and therefore may be an effective therapy option. Trial Registration: ClinicalTrials.gov identifier UNCOVER-1 (NCT01474512), UNCOVER-2 (NCT01597245), UNCOVER-3 (NCT01646177), IXORA-PEDS (NCT03073200), IXORA-S (NCT02561806), IXORA-R (NCT03573323), SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295), SPIRIT-H2H (NCT03151551).

Background: Remote monitoring was used to assess and manage skin diseases. Objective: To investigate to what extent smartphone photographs along with a self-reported body region (BR) score can be used to evaluate psoriasis severity. Methods: Psoriasis severity was assessed in the clinic using the psoriasis area and severity index and the physician’s global assessment. On the same day, the patients took a photograph of a representative lesion from 4 BR (head/neck, upper limbs, trunk, and lower limbs) and completed a questionnaire about BR score. The photographs were rated by 5 dermatologists. Intraclass correlation coefficients with 95% CIs were calculated. Results: Overall, 32 were included, of which 6% had almost clear, 69% had mild, and 25% had moderate psoriasis. Perfect agreement between the self-reported and the doctors’ BR score was observed for 59%, and near-perfect agreement (deviation of maximum 1 score) was 92%. The intraclass correlation coefficient between clinical and photographic psoriasis area and severity index was 0.78 (95% CI, 0.55-0.90), and for physician’s global assessment, perfect agreement was 53%. Conclusions: The agreement between psoriasis severity assessed clinically and by photographs was good in a study setting. This gives the opportunity to remotely assess psoriasis severity by combining photographs with self-reported BR scores.

The European Medicines Agency recently limited the use of oral Janus kinase inhibitors in certain patient populations, including those with atopic dermatitis. This cross-sectional study used the Danish national registers and Danish Skin Cohort to assess the prevalence of risk factors that potentially impact choice of treatment with oral Janus kinase inhibitors in adult patients with atopic dermatitis. From the Danish national registers and Danish Skin Cohort, 18,618 and 3,573 adults with atopic dermatitis, respectively, were identified. Half of the patients (49.5%) had, at some point, been registered to have at least 1 risk factor that could impact treatment with oral Janus kinase inhibitors. Non-modifiable risk factors recorded were cancer (5.6%), major adverse cardiovascular events (2.6%), venous thromboembolism (2.0%), smoking history (15.6%), and age ≥ 65 years (12.4%). Among patients ≥ 65 years of age, the mean (standard deviation) number of risk factors were 3 (1.4), and almost half of these patients had, at some point, been registered to have 1 or more non-modifiable risk factors in addition to their age. In conclusion, risk factors that may impact treatment with oral Janus kinase inhibitors were frequent in Danish adults with atopic dermatitis, especially among older individuals. Dermatologists need support and continuously updated long-term safety data when risk-evaluating patients with atopic dermatitis prior to initiation of advanced

Background Available network meta-analyses (NMAs) comparing the efficacy of biologics in nail psoriasis (NP) have not included recently approved biologics such as bimekizumab nor have they provided comparisons up to 1 year. Objective We conducted two NMAs that update and extend results from a previous NMA comparing biologics for achieving complete resolution of NP. Methods Bayesian NMAs were performed using a generalized linear model with a logit link to model the binary outcome of nail clearance at weeks 24–28 and 48–52. Results For the NMA at weeks 24–28, which included seven biologics and placebo, the absolute probability of achieving complete resolution of NP was highest for ixekizumab (46.4%; 95% credibility interval [CrI] 35.2–58.0), followed by brodalumab (37.1%; 95% CrI 17.1–62.2) and bimekizumab (30.3%; 95% CrI 12.7–53.9). For the NMA at weeks 48–52, which included six biologics, the absolute probability was highest for ixekizumab (77.2%; 95% CrI 51.1–93.4), followed by adalimumab (75.6%; 95% CrI 61.5–87.3) and brodalumab (71.9%; 95% CrI 38.4–93.2). Conclusion Among biologics included in these two NMAs, ixekizumab has the highest absolute probability of achieving complete resolution of NP. Results may help to inform treatment decisions for patients with NP.

Background Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure. Objectives To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and the number needed to harm (NNH) for one adverse event of special interest (AESI) to occur. Methods Pooled analysis from two randomized controlled trials in patients with moderate-to-severe plaque psoriasis (n = 1800). PSOLAR registry was used as safety reference data for NNH estimation. Results Rates of AESI with tildrakizumab were comparable with rates reported in PSOLAR. The NNH for one-year severe infection occurrence was 412 with tildrakizumab 200 mg, and negative for tildrakizumab 100 mg due to lower rates in reSURFACE trials; the NNH for malignancy was 990 for one year with tildrakizumab 100 mg (negative for tildrakizumab 200 mg); and the NNH for major adverse cardiovascular events was 355 for one year with tildrakizumab 200 mg (negative for tildrakizumab 100 mg). Conclusion Tildrakizumab demonstrated a favorable safety profile over 5 years with low rates of AESI, comparable to those of the PSOLAR. Consequently, the NNH for AESI with tildrakizumab were very high or negative due to lower event rates for tildrakizumab.

Whether response to an interleukin (IL-17) inhibitor is different in patients with previous exposure to an IL-17 inhibitor compared with patients with exposure to biologics with other cytokine targets remains to be elucidated. Therefore, the aim of this study was to assess whether previous exposure to an IL-17A inhibitor was associated with worse response than exposure to (an)other biologic(s). All patients in the DERMBIO register treated with an IL-17A inhibitor (secukinumab or ixekizumab) were included. With an absolute Psoriasis Area and Severity Index (PASI) ≤ 2 as response, the proportion of responders treated with IL-17A inhibitors was assessed in patients previously treated with another IL-17A inhibitor and compared with patients with previous exposure to (an)other biologic(s), using a χ2 test. In total, 100, 93 and 83 patients with previous exposure to an IL-17A inhibitor and 414, 372 and 314 patients with previous exposure to (an) other biologic(s) were assessed after 3, 6 and 12 months, respectively. No differences in the proportion of patients achieving PASI ≤ 2 were observed between the 2 groups after 3 months (54% vs 57%, p = 0.59), 6months (70% vs 66%, p = 0.42) and 12 months (69% vs 60%, p = 0.14). In conclusion, when treating patients with IL-17A inhibitors the cytokine target of the previous biologic does not appear to affect the response.

Abstract Extracellular matrix (ECM) remodeling of the skin is a continuous process necessary for maintaining tissue homeostasis. Type VI collagen (COL6) is characterized as a beaded filament, located in the dermal ECM, where COL6-α6-chain has been demonstrated upregulated in atopic dermatitis. The aim of this study was to develop and validate a competitive ELISA, targeting the N-terminal of COL6-α6-chain, named C6A6, and evaluate its associations with the dermatological condition’s atopic dermatitis, psoriasis, hidradenitis suppurativa, systemic lupus erythematosus, systemic sclerosis, urticaria, vitiligo, and cutaneous malignant melanoma in comparison, to healthy controls. A monoclonal antibody was raised and employed in an ELISA assay. The assay was developed, technically validated, and evaluated in two independent patient cohorts. Cohort 1 showed C6A6 was significantly elevated in patients with atopic dermatitis (p

Abstract Background While administrative health records such as national registries may be useful data sources to study the epidemiology of psoriasis, they do not generally contain information on disease severity. Objectives To develop a diagnostic model to distinguish psoriasis severity based on administrative register data. Method We conducted a retrospective registry-based cohort study using the Danish Skin Cohort linked with the Danish national registries. We developed a diagnostic model using a gradient boosting machine learning technique to predict moderate-to-severe psoriasis. We performed an internal validation of the model by bootstrapping to account for any optimism. Results Among 4016 adult psoriasis patients (55.8% women, mean age 59 years) included in this study, 1212 (30.2%) patients were identified as having moderate-to-severe psoriasis. The diagnostic prediction model yielded a bootstrap-corrected discrimination performance: c-statistic equal to 0.73 [95% CI: 0.71–0.74]. The internal validation by bootstrap correction showed no substantial optimism in the results with a c-statistic of 0.72 [95% CI: 0.70–0.74]. A bootstrap-corrected slope of 1.10 [95% CI: 1.07–1.13] indicated a slight under-fitting. Conclusion Based on register data, we developed a gradient boosting diagnostic model returning acceptable prediction of patients with moderate-to-severe psoriasis.

Background: The chronic systemic inflammation associated with psoriasis supposedly creates an undesirable milieu for a pregnancy, resulting in an increased risk of adverse pregnancy outcomes (APOs). Objective: To investigate the association between psoriasis and APOs as well as how the association differs according to psoriasis severity (mild and moderate-to-severe). Methods: This nationwide register-based case-control study collected data from 1973 to 2017. Cases were APOs (spontaneous abortion, ectopic pregnancy [EP], intrauterine fetal death, and stillbirth). Singleton live births were controls. Adjusted logistic regression models were used for statistical analyses. Results: In total, 42,041 (8.56%) APOs and 449,233 (91.44%) controls were included. EP was the only APO that was found to be statistically associated with psoriasis (odds ratio, 1.34; 95% CI, 1.06-1.68). Odds ratio for EP was the highest for women with moderate-to-severe psoriasis (odds ratio, 2.77; 95% CI, 1.13-6.76). The absolute risk of EP was 2.48% higher for women with moderate-to-severe psoriasis compared with women without psoriasis (3.98% vs 1.50%). Limitations: No access to clinical data confirming psoriasis severity. Conclusion: The present study found a significant association between EP and psoriasis (absolute risk of 3.98%). As EP is the leading cause of maternal morbidity and mortality in the first trimester of pregnancy, our findings call for particular care for women of reproductive age with psoriasis.

What is this summary about? This summary presents findings from recent research involving people with psoriasis, based on an article originally published in the Journal of the European Academy of Dermatology and Venereology. Psoriasis is a condition that primarily affects the skin. However, it can also influence people’s mental health, social activities, work, and relationships too. Current assessment tools used by doctors and nurses do not cover the complete experience of people with psoriasis, which often include other medical conditions and can leave these individuals feeling that treatment has not been successful. Researchers conducted a study in which people with psoriasis, doctors, and nurses were asked in virtual meetings and via questionnaires what freedom from disease in psoriasis means to them. What were the results? In addition to skin symptoms, the areas of mental health, well-being, treatment, and relationships with healthcare teams were found to be important aspects to be addressed. What do the results of the study mean? Focusing on all five aspects of freedom from disease will help people with psoriasis manage their psoriasis with confidence.

Introduction Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections.Methods and analysis BRodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Italy. A distributed database network approach is used, such that only aggregate data are exchanged between sites.Two types of designs are used: a case-time-control design to study acute effects of transient treatment and a variation of the new user active comparator design to study the effects of transient or chronic treatment. As comparators, inhibitors of TNF-α, inhibitors of IL-12 and IL-23, and other inhibitors of cytokine IL-17A are included.In the self-controlled case-time-control design, the risk of developing the outcome of interest during periods of brodalumab use is compared within individuals to the risk in periods without use.In the active comparator cohort design, new users of brodalumab are identified and matched to new users of active comparators. Potential baseline confounders are adjusted for by using propensity score modelling. For outcomes that potentially require large cumulative exposure, an adapted active comparator design has been developed.Ethics and dissemination The study is approved by relevant authorities in Denmark, Norway, Sweden, the Netherlands, Germany and Italy in line with the relevant legislation at each site. Data confidentiality is secured by the distributed network approach. Results will be published in peer-reviewed journals.Trial registration number EUPAS30280.

ObjectivePatients with psoriasis have an increased prevalence of type 2 diabetes when compared to the general population. Research suggests that type 2 diabetes (T2D) as well as obesity may have an impact on patients' response to treatment. This post-hoc analysis reports the efficacy of ixekizumab in treating moderate-to-severe psoriasis in patients with prediabetes or T2D.Method and materialsUNCOVER-1, UNCOVER-2, and UNCOVER-3 were three Phase 3, multicenter, randomized, double-blind, placebo-controlled trials that evaluated the efficacy and safety of ixekizumab in adult patients with moderate-to-severe psoriasis. Patients were aged ≥18 years with chronic moderate-to-severe psoriasis (defined as ≥10% body surface area affected, static Physician Global Assessment ≥3, and Psoriasis Area and Severity Index [PASI] ≥12 at screening and baseline) who were candidates for phototherapy or systemic therapy. UNCOVER-1, UNCOVER-2, and UNCOVER-3 participants received ixekizumab as per label (that is, an initial dose of two subcutaneous injections [160 mg in total] at Week 0, followed by 80 mg every 2 weeks through Week 12 and 80 mg every 4 weeks thereafter through Week 60).ResultsThe proportions of patients with prediabetes, T2D and normoglycemia that achieved PASI75, PASI90, and PASI100 at Week 60 were similar. Results suggest that patients with T2D were slower to achieve PASI100 than patients with prediabetes or those with normoglycemia. Ixekizumab had no effect on any metabolic markers in patients receiving the treatment.ConclusionsDespite the higher rate of obesity and extreme obesity in patients with prediabetes and T2D, ixekizumab was an efficacious treatment in treating patients with psoriasis.

BackgroundAn overlap between the skin disease rosacea and the headache disease migraine has been established; however, the magnitude of this overlap and the distribution between subtypes/phenotypes remains unclear.ObjectiveThe aim was to determine the magnitude of the overlap between rosacea and migraine, and to determine which subtypes/phenotypes were present in patients with concomitant rosacea and migraine.MethodsIn this cross-sectional study, 604 patients with a diagnosis of either rosacea or migraine were phenotyped through a face-to-face interview with clinical examination, to determine prevalence and phenotype of rosacea, and prevalence and subtype of migraine.ResultsWe found a prevalence of migraine of 54% in patients with rosacea, and a prevalence of rosacea of 65% in patients with migraine. Concomitant migraine was significantly associated with the rosacea features flushing (odds ratio = 2.6, 95% confidence interval = 1.4–4.7, p = 0.002), ocular symptoms (odds ratio = 2.4, 95% confidence interval = 1.5–3.9, p < 0.001), and burning (odds ratio = 2.1, 95% confidence interval = 1.3–3.4, p = 0.002), whereas papules/pustules were inversely related with concomitant migraine (odds ratio = 0.5, 95% confidence interval = 0.3–0.8, p = 0.006). No association was found between concomitant migraine and centrofacial erythema, rhinophyma, telangiectasia, edema, or dryness. Concomitant rosacea was not associated with any specific migraine subtype in patients with migraine.ConclusionThis study highlights a substantial overlap between rosacea and migraine, particularly in patients with certain rosacea features. Individuals with rosacea should be asked about concomitant migraine, and comorbidities should be considered when choosing between treatments.

Nail psoriasis is a chronic, difficult-to-treat condition affecting almost half of patients with psoriasis. It is associated with considerable social stigma and impairment of patients’ quality of life. The aim of this study was to assess improvements in objective measures of nail psoriasis among patients from the long-term extension of the UNCOVER-3 study who received the interleukin-17A inhibitor ixekizumab and had either any degree of nail psoriasis (Nail Psoriasis Severity Index (NAPSI) >=1) or significant nail psoriasis (fingernail NAPSI ≥ 16 and ≥ 4 fingernails involved) at baseline. Efficacy outcomes reported through week 264 included the mean percentage improvements from baseline in NAPSI score and the proportion of patients achieving nail psoriasis resolution (NAPSI=0). In UNCOVER-3, 56.9% (219/385) of patients had nail psoriasis at baseline; of those, 61.2% (134/219) had significant nail psoriasis. At week 60, a total of 66.9% and 59.1% of patients with baseline nail psoriasis and significant baseline nail psoriasis, respectively, reported complete clearance of nail psoriasis, an effect which was sustained through week 264. This analysis demonstrates that continuous treatment with ixekizumab in adult patients with moderate-to-severe-psoriasis through 264 weeks was associated with improvements and clearance of fingernail psoriasis, irrespective of the severity of nail psoriasis at baseline.

We present 2 cases of rosacea that were successfully managed with off-label treatment. The first is a case of painful, exuding papulopustular lesions of the nose treated with rifaximin, and the other is a case of severe, debilitating and painful flushing treated with sumatriptan. The cases support previous notions that gastrointestinal comorbidities may be related to papulopustular lesions and that flushing may be related to neurogenic inflammation and migraine. The cases also imply that a new approach to rosacea management, based on endotypes and comorbidities, may be warranted.

Background: Vitiligo is a depigmentation disorder associated with genetic loss of melanocytes and decreased melanin synthesis. The current literature is conflicting in regard to vitiligo patients' risk of cutaneous malignant melanoma and keratinocyte cancer. Objective: To investigate the risk of cutaneous malignant melanoma and keratinocyte cancer in vitiligo patients. Methods: We conducted a population-based study, including 2,339 subjects with a first-time vitiligo diagnosis between 1994 and 2017 and 23,293 age- and sex-matched (1:10) controls. To address surveillance bias, we included 12,380 subjects with a first-time diagnosis of lichen planus. Results: Age was the only significant factor for cutaneous malignant melanoma in comparison of vitiligo with controls and lichen planus (hazard ratio 1.04, 95% confidence interval [CI] 1.03-1.05; and hazard ratio 1.02, 95% CI 1.01-1.04, respectively). Similarly, age was a significant factor for keratinocyte cancer in comparison of vitiligo with controls and lichen planus (hazard ratio 1.07, 95% CI 1.06-1.07; and hazard ratio 1.06, 95% CI 1.05-1.07). Male sex was an additional factor for keratinocyte cancer in comparison of vitiligo with lichen planus (hazard ratio 1.38; 95% CI 1.09-1.75). Phototherapy did not increase the risk of receiving a diagnosis of cutaneous malignant melanoma or keratinocyte cancer in the vitiligo cohort. Conclusion: We observed no significant difference in cutaneous malignant melanoma or keratinocyte cancer risk among vitiligo subjects. Phototherapy use was not associated with a higher skin cancer risk in vitiligo compared with other skin diseases.

Identifying patient characteristics associated with achieving treatment response to biologics in patients with psoriasis could prevent expensive switching between biologics. The aim of this study was to identify patient characteristics that predict the efficacy of treatment for biologics that inhibit tumour necrosis factor-α, interleukin-12/-23, and -17A. The study investigated biologic-naïve patients from the DERMBIO registry treated with adalimumab, etanercept, infliximab, secukinumab, or ustekinumab. Multivariable logistic models were conducted to assess associations between patient characteristics and treatment response. A total of 2,384 patients were included (adalimumab n = 911; etanercept n = 327; infliximab n = 152; secukinumab n = 323; ustekinumab n = 671). Smoking (odds ratio 0.74; 95% confidence interval (CI) 0.56–0.97; p = 0.03) and higher bodyweight (odds ratio 0.989; 95% CI 0.984–0.994; p

Advances in technology have led to an increased number of studies investigating the microbiome in patients with psoriasis. This systematic review examined data regarding the oral and gut microbiota in patients with psoriasis and/or psoriatic arthritis and the effect of probiotics on the microbiota and severity of psoriasis. Of 1,643 studies, 23 were included (22 observational, 1 interventional). Studies examined the microbiota using culture or 16S rRNA gene sequencing analysis. All culture-based studies identified an increased presence of oral Candida in patients with psoriasis, whereas small variations in the oral microbiota were found in a 16S rRNA gene-based study. All 16S rRNA gene sequencing based studies agreed that the gut microbiota of patients with psoriatic disease differed from that of healthy controls, but the results were heterogeneous. Probiotics were associated with a significant improvement in the severity of psoriasis, but did not change microbiota. Overall, studies lacked relevant inclusion criteria and baseline information. In conclusion, the role of the microbiota in patients with psoriasis requires further investigation using more robust methods.

Abstract Introduction Rapid improvement of psoriasis is valued by patients and should be considered to be an important factor in treatment selection. We investigated Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) response rates within the first 12 weeks of treatment to compare the rapid response of 11 biologic therapies for moderate-to-severe psoriasis using Bayesian and Frequentist network meta-analyses (NMA). Methods A systematic literature review was conducted to identify phase 3, double-blind, randomized, controlled trials for adult patients with moderate-to-severe psoriasis treated with interleukin (IL)-17 (brodalumab, ixekizumab, secukinumab), IL-12/-23 (ustekinumab), IL-23 (guselkumab, risankizumab, tildrakizumab), or tumor necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, infliximab). Outcome measures extracted from 32 publications were ≥ 75, ≥ 90, or 100% improvement in PASI score (PASI 75, PASI 90, or PASI 100, respectively) at weeks 2, 4, 8, and 12 and DLQI (0,1), where score (0,1) indicates no effect on patient's life, at week 12. Bayesian NMA (BNMA) used fixed-treatment effect and random-baseline effect, normal independent models. Frequentist NMA (fNMA) was conducted as sensitivity analyses to test the robustness of the findings. Results Based on BNMA and fNMA, brodalumab and ixekizumab showed the most rapid treatment effects on PASI 75 at weeks 2, 4, and 8 and on PASI 90 and PASI 100 at weeks 2, 4, 8, and 12; ixekizumab overlapped with risankizumab on PASI 75 at week 12. Brodalumab, ixekizumab, and secukinumab yielded higher DLQI (0,1) gains at week 12 compared to all of the other biologics studied. Additional measures of quality of life were not assessed in this report. Conclusions Ixekizumab and brodalumab provide the most rapid response and earliest clinical benefit at week 2 among all of the biologics studied, including other biologic treatments such as secukinumab, ustekinumab, guselkumab, adalimumab, and etanercept. BNMA and fNMA results showed similar relative effect estimates and treatment rankings. Funding Eli Lilly and Company.

The initiation and evaluation of treatment with biologics for psoriasis is based on the Psoriasis Area Severity Index (PASI) and/or Dermatological Life Quality Index (DLQI). However, these indices do not always correlate well, and changes in the DLQI do not always follow changes in the PASI. Based on data from the Danish national registry (DERMBIO), this study investigated the correlation between changes in PASI and DLQI in a cohort of patients with moderate-to-severe psoriasis treated with biologics or apremilast using Spearman’s rank correlation analyses. The correlation analysis of 1,677 patients, of whom 276 had available data after 5 years, showed weak-to-moderate correlation between PASI and DLQI during a 5-year period and between changes in PASI and DLQI: 0.58 (p

Background & Aims: There are currently no validated claims-based indicators for identifying a worsening of disease in patients with inflammatory bowel disease (IBD). Therefore, we aimed to develop and validate indicators that identify flare-ups of IBD using data from Danish nationwide registries. Methods: Using Danish nationwide administrative data, we identified all patients with Crohn’s disease (CD) or ulcerative colitis (UC) who had at least one measurement of faecal calprotectin between 1 January 2015 and 31 June 2017. We tested several different claims-based indicators of disease flare-ups against levels of faecal (F-)calprotectin (no flare-up:

Early response to treatment with biologics might be important for the stability of psoriasis and long-term outcome. The aim of this study was therefore to assess whether risk of flares and drug survival are associated with disease activity in the first 6 months of treatment of psoriasis with biologics. Biologic-naïve patients from the Danish nationwide registry, DERMBIO, were grouped based on absolute Psoriasis Area and Severity Index (PASI) during the first 6 months of treatment, as: PASI = 0, PASI > 0–≤2, PASI > 2–≤ 4, and PASI > 4. Among 1,684 patients, 746 achieved PASI= 0, 485 PASI > 0–≤2, 246 PASI > 2–≤4, and 207 PASI > 4. Longer flare-free period and drug survival were observed for patients with lower PASI in the first 6 months of treatment (adjusted hazard ratios for flares (95% confidence interval) with PASI= 0 as reference: PASI > 0–≤2 (1.35 (1.11–1.72]), PASI > 2–≤ 4 (2.32 [1.80–2.99]), and PASI > 4 (2.38 [1.80–3.15])). In conclusion, a low PASI in the first 6 months of treatment with biologics in biologic-naïve patients with psoriasis was associated with a more stable disease course, lower risk of flares, and longer drug survival.